DETAILED ACTION
The following Office Action is in response to the Amendment filed on July 21, 2025. Claims 1, 3, 4, 7-13, 15, 16, 19, and 20 are currently pending.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
Concerning the “Claim Rejections – 35 U.S.C. §112” section on page 5 of the Applicant’s Response filed on July 21, 2025, the amendments to claims 8-10 and 15 to address the issues of indefiniteness have obviated the necessity of the rejections of the claims under 35 U.S.C. §112(b). Therefore, the rejections of the claims are withdrawn.
Response to Arguments
Concerning the “Claim Rejections – 35 U.S.C. §103” section on pages 5-8 of the Applicant’s Response filed on July 21, 2025, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant first argues that the combination of the Obana and Nikolchev references is improper due to impermissible hindsight. However, the examiner asserts that, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Although the applicant states that the motivation to combine is found in the applicant’s own disclosure, the examiner points to the motivation provided within the rejection, which is provided by knowledge provided within the Obana and Nikolchev references that states it would obvious to incorporate the stent system of Nikolchev into the guiding member of Obana as a simple substitution of one known stent system for another known stent system, which is cited in MPEP 2143(I) as a proper rationale for obviousness.
The applicant then argues that the Obana reference teaches away from modifying the distal filter with the Nikolchev reference given the distal filter is temporary, while the stent is permanent. However, the examiner asserts that the Obana reference has not been modified by teachings of the Nikolchev reference to have the distal filter attached to the guiding member. The Obana reference already teaches the distal filter being attached to the guiding member as is pointed out in the rejection of claim 3 under 35 U.S.C. §103 in the Non-Final Rejection filed on April 21, 2025. The Nikolchev reference has been used to modify the anchor of the Obana reference, not the distal filter of the Obana reference.
The applicant then argues that the elements of the Nikolchev reference that the examiner has interpreted as being “the supports” cannot be interpreted as such because they do not serve the distinct purpose of enabling the temporary attachment and removal functionality that is absent from the permanently implanted stents of the prior art. However, the examiner asserts that the applicant has too narrowly interpreted the term “support”. The limitation has been given its broadest reasonable interpretation as any element that provides support. Any additional functionality is extraneous and is not described within the claims. Because the elements of the Nikolchev provide support, they may properly be interpreted as supports.
Lastly, the applicant argues that the combination of the Obana and Nikolchev still does not teach the claimed invention because there is no teaching or suggestion in either reference to modify the permanent stent systems to include the specific attachment mechanism claimed. However, the examiner asserts that no specific attachment mechanism has been claimed. The claims simply recite “a stent and expandable supports securing the stent to the guiding member”, wherein the Nikolchev reference teaches structures which may be interpreted as supports. No other attachment mechanism is described, and the filter is simply taught as being attached to the guiding member, wherein the Obana reference teaches such an attachment. Therefore, the rejections of the claims under 35 U.S.C. §103 as being unpatentable over Obana in view of Nikolchev stand.
The applicant further argues that the Bonnette reference does not cure the deficiencies of the Obana and Nikolchev references. However, as discussed above, the Obana and Nikolchev references have not been found to be deficient in any teachings with regards to the independent claims. Furthermore, the Bonnette reference has not been used to modify the Obana and Nikolchev references, but has rather been utilized to modify the Obana reference alone. Thus, the applicant’s three-combination analysis of the Obana, Nikolchev, and Bonnette reference is irrelevant. Nevertheless, the applicant still argues that the modification of the Obana reference with the Bonnette reference is improper because there is a lack of motivation given the Bonnette reference is fundamentally different than the filter system of the Obana reference given the Bonnette reference is a permanent filter. However, the examiner asserts that a person having ordinary skill in the art would still look to other filter systems on ways to improve a filter system regardless of whether it was intended to be permanent or temporary, and that a motivation still exists to modify the Obana reference with the Bonnette reference to provide an additional expandable distal filter as in the Bonnette reference to provide a backup to catch any larger soft debris that is not caught by the first distal expandable filter (Bonnette; [¶ 0010]), which is a feature that would be beneficial to a filter system whether it is intended to be placed permanently or temporarily. Therefore, the rejections of the claims under 35 U.S.C. §103 as being unpatentable over Obana in view of Bonnette stand.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3 and 4 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 3 recites the limitation of “wherein the distal filter is attached to the guiding member”, which has already been recited in claim 1, therein failing to further limit the claim. Claim 4 is further rejected for being dependent on a claim that fails to further limit the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3, 4, 7, 8, 11-13, 15, 16, 19, and 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Obana et al. (US 2006/0100658, hereinafter Obana) in view of Nikolchev et al. (US 7,785,361, hereinafter Nikolchev).
Concerning claim 1, the Obana et al. prior art reference teaches an intravascular blood filter system (Figures 8-9), comprising: an expandable proximal filter (Figure 8; 50) adapted to be collapsed within a proximal sheath (Figure 8; 40); a distal articulatable sheath disposed distal to the proximal sheath (Figure 9; 30, distal sheath may be interpreted as being articulatable because it is capable of being articulated via assuming a predetermined shape [¶ 0055]); an expandable distal filter (Figure 9; 57) adapted to be collapsed within the distal articulatable sheath, wherein the distal articulatable sheath is adapted to be independently articulated relative to the proximal sheath and the proximal filter ([¶ 0055], via shape memory); a guiding member extending through the proximal sheath and the distal articulatable sheath (Figure 8; 10); wherein the expandable distal filter is attached to the guiding member (Figure 9; 10, 57); and at least one expandable anchor disposed adjacent the distal filter, wherein the at least one expandable anchor includes a stent (Figure 9; 11 | [¶ 0048], stent system may be placed over the guide wire 10, and is adjacent the guiding member), but the reference states that the stent is placed over the guiding member via a stent system, and does not necessarily teach that the stent is coupled to the guiding member, and it does not teach expandable supports securing the stent to the guiding member.
However, the Nikolchev reference teaches a stent system, therein being in the same field of endeavor as the Obana reference, given the Obana blood filter system includes a stent system, wherein the Nikolchev reference teaches the stent system (Figure 1A) including a stent (Figure 106) directly coupled to a guiding member (Figure 1A; 100), and supports (Figure 3C2; 320) securing the stent to the guiding member (Figure 3C1; 310), wherein said supports may be interpreted as expandable given they expand outward from the guiding member.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of invention to incorporate the stent system of the Nikolchev reference into the guiding member of the Obana reference as a simple substitution of one known stent system associated with a guiding member (the generic stent system placed over the guiding member of Obana) for another known stent system associated with a guiding member (the stent system with the stent directly coupled to the guiding member as in Nikolchev) which would yield the expected result of operating in effectively the same manner.
Concerning claim 3, the combination of the Obana and Nikolchev references as discussed above teaches the system of claim 1, wherein the Obana reference further teaches the distal filter being attached to the guiding member (Figure 9; 10, 57).
Concerning claim 4, the combination of the Obana and Nikolchev references as discussed above teaches the system of claim 3, wherein the Obana reference further teaches the guiding member being adapted to be moved distally relative to the distal articulatable sheath to expand the distal filter from a collapsed configuration within the distal articulatable sheath to an expanded configuration outside of the distal articulatable sheath to an expanded configuration outside of the distal articulatable sheath ([¶ 0056], filter is deployed from the guide wire, which is fed through the sheaths).
Concerning claim 7, the combination of the Obana and Nikolchev references as discussed above teaches the system of claim 1, wherein the Nikolchev reference further teaches the stent being self-expandable (Nikolchev; Column 2, Lines 52-55).
Concerning claim 8, the combination of the Obana and Nikolchev references as discussed above teaches the system of claim 1, wherein the Obana reference further teaches the at least one expandable anchor being disposed proximal to the distal filter (Figure 9; 11).
Concerning claims 11 and 12, the combination of the Obana and Nikolchev references as discussed above teaches the system of claim 1, wherein the Obana reference further teaches the distal articulatable sheath being adapted to bend relative to the proximal sheath and the proximal filter by assuming a preset bent configuration ([¶ 0055]).
Concerning claim 13, the combination of the Obana and Nikolchev references as discussed above teaches the system of claim 1, wherein the Obana reference further teaches the distal articulatable sheath being adapted to be bent, to be axially translated, and to be rotated, relative to the proximal sheath and the proximal filter ([¶ 0054-0055]).
Concerning claim 15, the combination of the Obana and Nikolchev references as discussed above teaches the system of claim 1, wherein the Nikolchev reference teaches the at least one expandable anchor being attached to the guiding member (Nikolchev; Figure 1A; 106).
Concerning claim 16, the Obana et al. prior art reference teaches an intravascular blood filter system (Figures 8-9), comprising: an expandable proximal filter (Figure 8; 50) adapted to be collapsed within a proximal sheath (Figure 8; 40); a distal articulatable sheath disposed distal to the proximal sheath (Figure 9; 30, distal sheath may be interpreted as being articulatable because it is capable of being articulated via assuming a predetermined shape [¶ 0055]); a guiding member extending through the proximal sheath and the distal sheath (Figure 9; 10), an expandable distal filter (Figure 9; 57) attached to the guiding member (Figure 9; 10) and adapted to be collapsed within the distal articulatable sheath, wherein the distal articulatable sheath is adapted to be independently articulated relative to the proximal sheath and the proximal filter ([¶ 0055], via shape memory), and at least one expandable anchor disposed adjacent the distal filter, wherein the at least one expandable anchor includes a stent (Figure 9; 11 | [¶ 0048], stent system may be placed over the guide wire 10, and is adjacent the guiding member), but the reference states that the stent is placed over the guiding member via a stent system, and does not necessarily teach that the stent is coupled to the guiding member, and it does not teach expandable supports securing the stent to the guiding member.
However, the Nikolchev reference teaches a stent system, therein being in the same field of endeavor as the Obana reference, given the Obana blood filter system includes a stent system, wherein the Nikolchev reference teaches the stent system (Figure 1A) including a stent (Figure 106) directly coupled to a guiding member (Figure 1A; 100), and supports (Figure 3C2; 320) securing the stent to the guiding member (Figure 3C1; 310), wherein said supports may be interpreted as expandable given they expand outward from the guiding member.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of invention to incorporate the stent system of the Nikolchev reference into the guiding member of the Obana reference as a simple substitution of one known stent system associated with a guiding member (the generic stent system placed over the guiding member of Obana) for another known stent system associated with a guiding member (the stent system with the stent directly coupled to the guiding member as in Nikolchev) which would yield the expected result of operating in effectively the same manner.
Concerning claim 19, the combination of the Obana and Nikolchev references as discussed above teaches the system of claim 16, wherein the Obana reference further teaches the at least one expandable anchor being disposed adjacent the distal filter (Figure 9; 11).
Concerning claim 20 the combination of the Obana and Nikolchev references as discussed above teaches the system of claim 1, wherein the Obana reference further teaches the distal articulatable sheath being adapted to be bent, to be axially translated, and to be rotated, relative to the proximal sheath and the proximal filter ([¶ 0054-0055]).
Claim(s) 1, 9, and 10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Obana et al. (US 2006/0100658, hereinafter Obana) in view of Bonnette et al. (US 2010/0268264, hereinafter Bonnette).
Concerning claim 1, 9, and 10, the Obana et al. prior art reference teaches an intravascular blood filter system (Figures 8-9), comprising: an expandable proximal filter (Figure 8; 50) adapted to be collapsed within a proximal sheath (Figure 8; 40); a distal articulatable sheath disposed distal to the proximal sheath (Figure 9; 30, distal sheath may be interpreted as being articulatable because it is capable of being articulated via assuming a predetermined shape [¶ 0055]); an expandable distal filter (Figure 9; 57) adapted to be collapsed within the distal articulatable sheath, wherein the distal articulatable sheath is adapted to be independently articulated relative to the proximal sheath and the proximal filter ([¶ 0055], via shape memory); a guiding member extending through the proximal sheath and the distal articulatable sheath (Figure 8; 10); ); wherein the expandable distal filter is attached to the guiding member (Figure 9; 10, 57); and at least one expandable anchor disposed adjacent the distal filter, wherein the at least one expandable anchor includes a stent (Figure 9; 11 | [¶ 0048], stent system may be placed over the guide wire 10, and is adjacent the guiding member), but the reference states that the stent is placed over the guiding member via a stent system, and does not necessarily teach that the stent is coupled to the guiding member, and it does not teach expandable supports securing the stent to the guiding member.
However, the Bonnette reference teaches an intravascular blood filter system that includes an expandable distal filter (Figure 1; 24), which includes an additional expandable distal filter (Figure 1; 26) distal to the first expandable distal filter, wherein said additional expandable distal filter includes expandable supports securing the expandable distal filter to a guiding member (Figure 4; 48), wherein said additional expandable filter may be interpreted as an expandable anchor or stent given it expands and anchors into the blood vessel.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of invention to have the intravascular blood filter system of the Obana reference include the additional expandable distal filter distal to the first expandable distal filter as in the Bonnette reference, therein having the at least one expandable anchor include, a first expandable anchor in the form of the stent of Obana, a distal filter as taught by Obana, and a second expandable anchor in the form of an additional expandable filter including expandable supports, wherein said second expandable member may be defined as the stent that includes expandable supports securing the stent to the guiding member, wherein including the second expandable anchor of Bonnette would allow the system to provide a backup to catch any larger soft debris that is not caught by the first distal expandable filter (Bonnette; [¶ 0010]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN TRUYEN TON whose telephone number is (571)270-5122. The examiner can normally be reached Monday - Friday; EST 10:00 AM - 6:30 PM.
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/MARTIN T TON/Examiner, Art Unit 3771 11/4/2025
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